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Risk of Pneumothorax With and Without Chest Tube Clamping in Patients With Pleural Pathology

Risk of 24 Hour-pneumothorax After Chest Tube Removal With and Without Chest Tube Clamping in Patients With Pleural Pathology at the National Institute of Respiratory Diseases

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05243316
Enrollment
93
Registered
2022-02-17
Start date
2021-12-22
Completion date
2023-04-15
Last updated
2023-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chest Tube, Pleural Diseases, Pneumothorax

Keywords

Chest tube, Pneumothorax, Pleural Diseases

Brief summary

Through this randomized controlled clinical trial, we aim to identify whether there is a difference in the incidence of 24 hour pneumothorax after chest tube removal, in two blindly randomized groups of patients: The first group with chest tube clamping 6 hours prior to removal, and the second group there will be no chest tube clamping. The data will be prospectively collected from patient records from the National Institute of Respiratory Diseases Ismael Cosío Villegas.

Detailed description

Patients with an indication of chest tube removal will be randomized to two possible arms: clamping (for 6 hours before removal) or not clamping (immediate removal). Incidence of 24hour pneumothorax after chest tube removal will be recorded.

Interventions

PROCEDUREClamping

There will be a randomized selection of patients who will have a clamping of the chest tube 6 hours prior to chest tube removal.

PROCEDURENon Clampling

There will be a randomized selection of patients who wont have chest tube clamping 6 hours prior to chest tube removal.

Sponsors

National Institute of Respiratory Diseases, Mexico
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

Randomizing will be masked, as well as data analysis.

Intervention model description

Randomized controlled trial

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Patients aged 16 years and more. * Patients hospitalized in the National Institute of Respiratory Diseases. * Patients who had a chest tube placement during their stay at the hospital, by any cause.

Exclusion criteria

* Patients who refuse to sign the informed consent and who refuse to participate in the study. * Patients who die before randomization. * Patients who gets chest tube removal before being randomized.

Design outcomes

Primary

MeasureTime frameDescription
Incidence of pneumothorax after chest tube removal with chest tube clampingAfter 24 hours of procedureCases of pneumothorax after chest tube removal despite clamping
Incidence of pneumothorax after chest tube removal without chest tube clampingAfter 24 hours of procedureCases of pneumothorax after chest tube removal despite clamping

Secondary

MeasureTime frameDescription
Hospital days of stayThrough study completion, an average of 1 monthHospital days of stay

Countries

Mexico

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026